Study on Blinatumomab and Tyrosine Kinase Inhibitor Therapy for Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT04329325

Provider View

This clinical trial is testing whether adding the drug blinatumomab to standard treatment with tyrosine kinase inhibitors (TKIs) like dasatinib can improve outcomes for people with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Patient Parameters

Program Overview

The study aims to find out if combining blinatumomab with TKI therapy, such as dasatinib, can be more effective in treating people with Ph+ ALL. Researchers hope to enhance the response to the usual treatment of corticosteroids and TKI therapy by including blinatumomab.

Description

Pre-Phase:

  • Patients may receive corticosteroids and/or hydroxyurea before starting the main treatment.
  • A 7-day corticosteroid pre-phase is recommended before beginning TKI therapy.
  • If the leukemia is progressing, the main treatment can start earlier.

Induction Therapy:

  • Involves taking dexamethasone with TKI, usually starting with dasatinib.
  • Dexamethasone is given for 24 days, then gradually reduced.
  • TKI continues throughout.
  • Methotrexate may be given to prevent cancer in the brain and spinal cord.
  • Bone marrow tests are done to check for cancer cells.

Consolidation Therapy:

  • For patients who respond well to induction therapy.
  • Includes cycles of blinatumomab and continuous TKI.
  • Blinatumomab is given in cycles with breaks in between.
  • Bone marrow tests and brain/spinal cord cancer prevention continue.

Maintenance Therapy:

  • For patients who achieve complete molecular response.
  • Involves additional cycles of blinatumomab and continuous TKI.
  • Regular assessments and cancer prevention measures continue.

Follow-Up:

  • TKI maintenance is suggested but not mandatory.
  • Long-term follow-up for survival and relapse outcomes.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent.
  • Aged 18 years or older.
  • Specific liver function test results within acceptable limits.
  • Confirmed diagnosis of Ph+ ALL.
  • No prior ALL treatment beyond certain medications.
  • Good organ function.
  • Willing to use birth control during and after treatment.
  • ECOG performance status of 0-2.

Exclusion Criteria

  • Philadelphia chromosome-negative ALL.
  • Certain types of B-cell ALL.
  • Active disease outside the bone marrow, including the brain.
  • Known resistance to dasatinib.
  • Unable to take oral medication.
  • Specific kidney function test results not met.
  • Certain heart conditions.
  • Active hepatitis B or C infection.
  • HIV infection unless well-controlled.
  • Need for ongoing immune-suppressing therapy.
  • Other active cancers requiring treatment.
  • Uncontrolled infections.
  • Significant neurological disorders.
  • Any other condition deemed unsuitable by the doctor.

Locations

FACILITYZIPCITYSTATE
Mount Sinai Hospital10029New YorkNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York

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